Clinical Pharmacology Lead (4839031_Groton)
- Provides clinical pharmacology leadership on multi-disciplinary study teams for primarily COVID-19 antiviral programs, post-approval commitments, and product maintenance and defense.
- Provides clinical pharmacology components at project level (including clinical development plan), at study level (including protocols, analysis plans, clinical conduct, and study reports) and to global regulatory submission documents (IB, IND, pediatric plans, NDA, MAA).
- Responsible for interfacing with partner lines (e.g. clinical assay group, statistics, pharmacometrics) to ensure appropriate support for assigned programs and studies
- Accountable for ensuring appropriate design and implementation of a clinical modeling and simulation plan and interpreting results.
- Provides clinical pharmacology support and leadership in various regulatory interactions.
- Assures that the clinical pharmacology strategy serves the overall objectives of the clinical program and is designed and executed to the highest scientific standards and delivers the data required to fulfill regulatory requirements.
- Responsible for implementing clinical pharmacology best practices.
- Represent clinical pharmacology to senior levels of the organization.
- Influences environment outside of Pfizer through methods such as publication and presentations.
- Responsible for addressing, writing and reviewing regulatory queries and labeling requests to support maintenance.
- PhD/PharmD with 9+ years of drug development experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics
- Strong quantitative skills and expertise (e.g. experience in population modeling, literature meta-analyses, and clinical trial simulations) with hands-on implementation of tools such as NONMEM, R, SAS, or WinBUGS for data analysis and handling.
- Excellent written and verbal communication skills.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Minimal travel due to business necessity
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Medical